ResMed Mirage Activa User manual

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Mirage Activa™Nasal Mask
USER’S GUIDE
English
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©2012 ResMed Ltd.
©2012 ResMed Ltd.
Mask Cushion
Bulle du masque
Almohadilla de la mascarilla
Almofada da máscara
Headgear clips
Clips du harnais
Broches del arnés para la cabeza
Clipes do arnês
Ports cap
Bouchon des ports
Tapa de los puertos
Tampa das portas
Mask Elbow
Coude du masque
Codo de la mascarilla
Cotovelo da máscara
Vent cover
Cache des orifices de ventilation
Cubierta de la ventilación
Tampa do dispositivo de ventilação
Short air tubing
Tuyau à air court
Tubo de aire corto
Tubo de ar curto
Swivel
Pièce pivotante
Pieza giratoria
Peça giratória
Upper Velcro®straps
Bandes Velcro®supérieures
Correas superiores de Velcro®
Correias de Velcro®superiores
Cuff
Manchon
Mango
Manga
Mask Frame
Entourage rigide
Armazón de la mascarilla
Armação da máscara
Cushion clip
Clip de la bulle
Traba de la almohadilla
Clipe da almofada
Forehead pads
Tampons frontaux
Almohadillas para la frente
Almofadas da testa
Lower Velcro straps
Bandes Velcro inférieures
Correas inferiores de Velcro
Correias de Velcro inferiores
Forehead support
Support frontal
Apoyo para la frente
Suporte da testa
ActiveCell™
Headgear assembly
Harnais / Arnés para la cabeza / Montagem do arnês

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©2012 ResMed Ltd.
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©2012 ResMed Ltd.
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ENGLISH
Mirage Activa™Nasal Mask
The MIRAGE ACTIVA™nasal mask is an accessory to a non-
continuous ventilator (respirator), intended for multi-patient use
for adult patients prescribed continuous positive airway pressure
(CPAP) or bilevel therapy in hospital, clinic, and/or home
environments.
CAUTION
In the USA, federal law restricts this device to sale by or on the
order of a physician.
MEDICAL INFORMATION
Note: The mask system does not contain latex materials.
WARNINGS
•This mask should be used only with CPAP or bilevel systems
recommended by your physician or respiratory therapist. A
mask should not be used unless the CPAP or bilevel system is
turned on and operating properly. The exhalation device
should never be blocked.
Explanation of the Warning: CPAP or bilevel systems are
intended to be used with special masks with connectors
which have vent holes or separate exhalation devices to allow
continuous flow of air out of the mask. When the CPAP or
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bilevel device is turned on and functioning properly, new air
from the flow generator flushes the exhaled air out through
the attached mask exhalation port. However, when the CPAP
or bilevel device is not operating, enough fresh air will not be
provided through the mask, and exhaled air may be
rebreathed. Rebreathing of exhaled air for longer than several
minutes can in some circumstances lead to suffocation. This
warning applies to most models of CPAP or bilevel systems.
•The exhaust vent flow is lower at lower mask pressures (see
“Pressure/Flow Curve” on page 9). If the mask pressure during
expiration is too low, there may not be enough exhaust vent
flow to completely flush the air delivery hose of exhaled air
before the start of the next inspiration.
•The MIRAGE ACTIVA features an elbow that can be easily
removed while the mask is fitted. The mask should not be
used with the elbow attached unless the CPAP or bilevel
system is turned on and operating properly.
•The mask must be cleaned and disinfected/sterilized if it is
used between patients. Refer to the section “Cleaning the
Mask between Patients” for details.
•If oxygen is used with the CPAP or bilevel device, the oxygen
flow must be turned off when the flow generator is not
operating.
Explanation of the Warning: When the CPAP or bilevel
device is not in operation, and the oxygen flow is left on,
oxygen delivered into the ventilator tubing may accumulate
within the flow generator enclosure. Oxygen accumulated in
the CPAP or bilevel device enclosure will create a risk of fire.
This warning applies to most types of CPAP or bilevel flow
generators.
•Please refrain from smoking while oxygen is in use.
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ENGLISH
•Using a mask may cause tooth, gum or jaw soreness or
aggravate an existing dental condition. If symptoms occur,
consult your physician or dentist.
Note: At a fixed flow rate of supplemental oxygen flow, the inhaled
oxygen concentration will vary depending on pressure settings,
patient breathing pattern, mask selection, and leak rate.
PARTS OF THE MASK
See Figure A for a list of all parts.
The MIRAGE ACTIVA mask cushion uses ResMed's innovative
ACTIVECELL™technology. The ACTIVECELL is an expandable
chamber that inflates during therapy. This technology means that
the MIRAGE ACTIVA is "self sealing" as it responds to factors that
cause leak. This provides you with a better seal, especially when
you are moving during the night. The ACTIVECELL technology
does not require as much headgear strap tension as other masks,
which makes the MIRAGE ACTIVA more comfortable to use.
FITTING THE MASK
Note: Before fitting the mask, refer to the section on “Cleaning the
Mask in the Home” on page 6.
1Squeeze one of the headgear clips to release it from the mask
frame (Fig. B-1).
2Place the mask cushion over your nose.
3Pull the headgear over your head (Fig. B-2). Make sure the
lower straps pass below your ears, and the upper straps pass
over your forehead.
4Connect the free headgear clip to the mask frame (Fig. B-3).
5Adjust the lower (Fig. B-4) and then the upper (Fig. B-5)
straps of the headgear so the cushion sits loosely on your
face. Do not tighten the headgear straps at this stage.
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6The pads of the forehead support should lightly touch your
forehead when the mask is in place.
Adjust the forehead support by depressing its tab and moving
it to one of the other slot positions (Fig. C-7).
7Connect one end of the main air tubing to your CPAP or
bilevel device and the other end to the swivel.
Note: The swivel, short air tubing, and mask elbow are supplied
assembled.
8Connect the mask elbow to the mask frame. To do this, firmly
push the mask elbow onto the mask frame until it clicks into
place (Fig. B-6).
Check that you have connected the mask elbow correctly by
rotating it. Be careful not to squeeze the sides of the elbow as
it may release from the mask frame. If the mask elbow is fitted
correctly, it should rotate freely and not separate from the
mask frame.
9The fitted mask should look like this (Fig. B-7).
10 Turn your flow generator on. If you feel air leaks around the
cushion, reposition the mask on your face to achieve a better
seal. You may also need to readjust the headgear straps or
forehead support.
Do not over-tighten the straps. The straps should be adjusted
so that the ACTIVECELL is moderately and evenly expanded as
shown in Figure B-8.
The ACTIVECELL should not be collapsed (Fig. B-9) or over-
expanded (Fig. B-10).
Take time to adjust the straps and the position of the mask to
achieve a comfortable and secure fit. If you feel excessive
pressure on your nasal bridge or upper lip, adjust the
forehead support.
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ENGLISH
Note: Select "Standard" as the mask option, when using ResMed
AutoSet™ devices.
REMOVING THE MASK
To remove the MIRAGE ACTIVA mask, squeeze the headgear clips
(Fig. C-a). This releases the headgear clips from the mask frame.
Pull the mask and headgear away from your head.
Note: Do not pull the headgear off your head without releasing the
headgear clips first.
TIP!
You can detach the elbow from themask frame while wearing the
mask (see “Disassembling For Cleaning”). This is useful when
therapy needs to be stopped for a short time; for example if you
need to go to the bathroom.
DISASSEMBLING FOR CLEANING
1Detach the mask elbow. To do this, squeeze the raised dots
on the sides of the mask elbow while pulling it away from the
mask frame (Fig. C-1).
2Disconnect and separate the main air tubing, short air tubing,
mask elbow, and vent cover (Fig. C-2).
Notes
•To prevent damage to the short air tubing, disconnect it by
holding it at the cuff.
•The swivel does not need to be disconnected from the short air
tubing.
3Squeeze the headgear clips to release them from the mask
frame. Unfasten the Velcro® straps and unthread the upper
headgear straps through the slots of the forehead support.
4Remove the ports cap from the mask frame (Fig. C-3).
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5Detach the cushion assembly from the mask frame. To do
this, squeeze the two side latches on the cushion clip until
they disengage from the mask frame (Fig. C-4). Then pull the
mask cushion assembly out and away from the mask frame
(Fig. C-5).
6Remove the cushion clip from the mask cushion. To do this,
roll back one end of the ACTIVECELL and pull the cushion clip
out (Fig. C-6).
7Depress the forehead support tab and move it past the top
slot position (Fig. C-7). This allows you to remove the
forehead support from the mask frame.
Pull firmly at the base of the forehead pad plugs to release the
forehead pads from the forehead support.
CLEANING THE MASK IN THE HOME
Note: Wash the headgear before first time use, as the dye may run.
It is important to always hand wash the headgear.
WEEKLY
Hand wash the headgear in lukewarm, soapy water. Use pure
soap (see first caution below). Rinse well and allow it to air dry
out of direct sunlight.
DAILY/AFTER EACH USE
Hand wash the mask components in lukewarm, soapy water. Use
pure soap (see first caution below). Rinse the components well
and allow them to air dry out of direct sunlight.
CAUTIONS
•Do not use solutions containing bleach, chlorine, alcohol,
aromatics, moisturizers, antibacterial agents, or scented oils
to clean any part of the mask system or air tubing. These
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ENGLISH
solutions may cause damage and reduce the life of the
product.
•Do not expose any part of the mask system or tubing to
direct sunlight as it may cause the product to deteriorate.
•If any visible deterioration of a mask component is apparent
(cracking, crazing, tears, etc), the mask component should
be discarded and replaced.
REPROCESSING THE MASK BETWEEN
PATIENTS
The mask should be reprocessed when used between patients.
Cleaning, disinfection and sterilization instructions are available
from the ResMed website,
www.resmed.com/masks/sterilization/americas. If you do not
have Internet access, please contact your ResMed representative.
REASSEMBLING THE MASK
1Attach the forehead pads to the forehead support. To do this,
place the forehead pad plugs into the two round holes of the
forehead support. Then push firmly behind the base of the
forehead pad plugs (Fig. D-1) until the tip of the plug is
securely seated over the hole. The base of the forehead pad
plug should be flush against the forehead support.
2Reconnect the forehead support to the mask frame
(Fig. D-2). Depress the tab and move the forehead support
into one of the four slot positions.
3Fit the cushion clip into the groove of the mask cushion.
Ensure the cut outs under the cushion clip latches are aligned
with the blocks in the groove of the mask cushion.
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Fit the top section first (Fig. D-3), then work your way
around, inserting the cushion clip into the mask cushion.
Ensure that the cushion clip does not pinch any part of the
mask cushion (Fig. D-4). The cushion clip should fit snugly
inside the groove of the mask cushion.
4Attach the cushion assembly to the mask frame. To do this,
align the two side latches on the cushion clip to the top two
holes on the mask frame (Fig. D-5). Then push the cushion
assembly onto the mask frame firmly until the latches click
into place. Ensure the bottom latch is also secure (Fig. D-6).
5Push the ports cap onto the mask ports (Fig. D-7).
6Attach the vent cover to the mask elbow. To do this, slide the
vent cover along the elbow until the tops of the vent cover
(Fig. D-8b) and the ridge of the vent opening (Fig. D-8a) are
aligned. Then push the vent holes (Fig. D-9c) in and slide the
vent cover up over the ridge of the vent opening (Fig. D-9a &
Fig. D-9b). The fitted vent cover should look like Fig. D-10.
Ensure that the lip of the vent cover is securely seated over
the ridge of the vent opening. It should form a perfect circle
around the ridge of the vent opening and not be distorted.
7Connect the short air tubing to the mask elbow.
8Connect the headgear clips to the mask frame.
9Thread the upper straps of the headgear through the slots on
the forehead support and fasten the Velcro straps (Fig. D-11).
The headgear label should face outwards and be near your
neck when fitted.
10 Connect the swivel to the main air tubing ready for next use
(Fig. D-12).
11 When ready for use, connect the mask elbow to the mask
frame (Fig. B-6).
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ENGLISH
TECHNICAL SPECIFICATIONS
PRESSURE/FLOW CURVE
The following graph shows the rate of air flow through the mask
vents at varying mask pressures.
DEAD SPACE INFORMATION
The dead space of the MIRAGE ACTIVA mask is 127mL.
Explanation: Dead space is the empty volume of the mask up to
the elbow.
LIMITED WARRANTY
ResMed warrants that your ResMed mask system, including its
components: mask frame, cushion, headgear, tubing and other
accessories (“Product”) shall be free from defects in material and
workmanship for a period of ninety (90) days from the date of
purchase by the initial consumer.
For further details refer to the Warranty.
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4 5 6 7 8 91011121314151617181920
Exhaust Vent Pressure / Flow Characteristics
Pressure (cm H2O)
Flow (L/min)
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www.resmed.com Waking people up to sleep
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Manufacturer:
ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
Distributed by:
ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA
ResMed (UK) Ltd 96 Milton Park Abingdon Oxfordshire OX14 4RY UK
See www.resmed.com for other ResMed locations worldwide.
For patent information, see www.resmed.com/ip.
Velcro is a registered trademark of Velcro Industries B.V.
Activa, ActiveCell, AutoSet, AutoSet T, Mirage and are trademarks of
ResMed Ltd.
© 2012 ResMed Ltd. 608335/1'PI 2012-04